**Clinical Quality Assurance Auditor - Cambridge**

Job Summary:

I am currently working with a very interesting and exciting traditional Pharmaceutical company, based in Cambridge, who are actively seeking a Clinical Quality Assurance Auditor to join their team! This professional will have specific expertise in the planning, conduct and follow up of GCP Quality Audits as well as specific working knowledge across GCP in the Quality field. This role is perfect for a professional coming from a CRO or smaller pharma background, looking to progress.

Requirements:

The CQA Auditor is responsible for Quality Assurance aspects of clinical trials, ensuring trials conform to ICH-GCP, other applicable regulations and the relevant Standard Operating Procedures (SOPs). The QA Auditor is independent of the Clinical Research Team.

Create QA SOPs required for the proper functioning of the clinical trial process

Act as Quality Project Lead (QPL) on assigned studies, ensuring quality related oversight of projects and to act as a QA point of contact for study team members

Audit the quality of the clinical trial against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements; prepare audit reports within a timely manner; identify any failure to meet the standards and address the issue immediately with the Project Manager; and if required, with Senior Management

Provide regular feedback to the QA Audit Management team about the quality standards practiced in the company and give recommendations for their improvement

Provide support and advice to other departments for quality improvement

Provide GCP/GMP consultancy and advice in response to questions raised by individuals from the organization

Actively participate in training sessions and workshops, including presenting reports from any conferences attended

Ensure timely completion and documentation of all training requirements

Ensure that systems and processes agreed and implemented by management will ensure that Clinical Trials have been performed, and data is generated, in compliance with ICH-GCP and other applicable regulations

Be aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and advise on their use and compliance

Other duties, as required by the Quality Assurance department

Profile:

A university degree in a biomedical or related life science, nursing or engineering qualification is beneficial

Minimum 5+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

At least 2 years of auditing experience within a Clinical Research or Pharmaceutical environment is mandatory

Diplomatic and professional oral and written communication skills to be able to convey and discuss audit findings, good organisational skills and personal presentation

Methodical and meticulous, with excellent attention to detail

Ability to proactively manage multiple responsibilities and tasks

Experience working in a team environment under time and resource pressures

Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications

Ability to review data and procedures in detail and the ability to see the greater overall perspective Understanding of the principles of ICH-GCP and all applicable regulatory requirements

Ability to guide, supervise and motivate less experienced staff

Ability to train junior members of the QA Compliance team on relevant QA systems, processes and procedures

Ability to maintain confidentiality of employee data and information during interactions with staff at all levels Experience and success, working in a busy team environment under time pressure

Must be fluent in the English language (written & spoken), additional languages are of advantage

Additional:

This role is office based in Cambridge

Moderate travel availability across Europe is a prerequisite

Overnight stays may be required

For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!

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